Trial Outcomes & Findings for REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue (NCT NCT04525183)
NCT ID: NCT04525183
Last Updated: 2024-11-15
Results Overview
Changes in fatigue interference were measured using the validated 7-item interference scale of the Fatigue Symptom Inventory scale. Interference items assessed the degree to which fatigue interfered with general levels of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Fatigue interference was scored on an 11-point scale, ranging from 0 (no interference) to 10 (extreme interference). Interference items were summed to obtain a total perceived interference score, with higher scores indicating greater fatigue interference.
COMPLETED
NA
49 participants
Change from baseline to 4-, 8-, and 12-weeks
2024-11-15
Participant Flow
Participant milestones
| Measure |
Run-in Period
Tested and refined the REVITALIZE intervention in a sample of up to 5 patients with ovarian cancer who report fatigue associated with PARPi in a single-arm pre-pilot run-in phase of a 6-week ACT intervention (REVITALIZE).
|
Enhanced Usual Care (EUC)
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
23
|
21
|
|
Overall Study
COMPLETED
|
4
|
23
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
5
|
Reasons for withdrawal
| Measure |
Run-in Period
Tested and refined the REVITALIZE intervention in a sample of up to 5 patients with ovarian cancer who report fatigue associated with PARPi in a single-arm pre-pilot run-in phase of a 6-week ACT intervention (REVITALIZE).
|
Enhanced Usual Care (EUC)
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
|
Overall Study
Study non-compliance
|
0
|
0
|
1
|
|
Overall Study
Recurrent disease before starting on study
|
0
|
0
|
1
|
Baseline Characteristics
REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/non-Hispanic
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian/non-Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other/non-Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
High school or less
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
Some college
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
College or higher
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Employment
Full-time/part-time
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Employment
Unemployed
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment
Disabled
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Employment
Retired
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Employment
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Relationship status
Married/Cohabitating
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Relationship status
Single, never married
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Relationship status
Divorced/separated
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Relationship status
Widowed/other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ovarian cancer stage
Stage I-II
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ovarian cancer stage
Stage III
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ovarian cancer stage
Stage IV
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Germline mutation
Yes
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Germline mutation
No
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
PARP inhibitor indication
Maintenance after first line
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
PARP inhibitor indication
Maintenance for platinum-sensitive recurrence
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
PARP inhibitor indication
Other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Time on PARP inhibitor
|
333.9 days
STANDARD_DEVIATION 302.9 • n=5 Participants
|
453.2 days
STANDARD_DEVIATION 290.1 • n=7 Participants
|
390.8 days
STANDARD_DEVIATION 299.5 • n=5 Participants
|
|
Time since diagnosis
|
2.6 years
n=5 Participants
|
2.2 years
n=7 Participants
|
2.5 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksChanges in fatigue interference were measured using the validated 7-item interference scale of the Fatigue Symptom Inventory scale. Interference items assessed the degree to which fatigue interfered with general levels of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Fatigue interference was scored on an 11-point scale, ranging from 0 (no interference) to 10 (extreme interference). Interference items were summed to obtain a total perceived interference score, with higher scores indicating greater fatigue interference.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Fatigue Interference
Week 4
|
2.80 score on a scale (describing the units)
Standard Deviation 1.93
|
2.56 score on a scale (describing the units)
Standard Deviation 1.25
|
|
Fatigue Interference
Baseline
|
3.76 score on a scale (describing the units)
Standard Deviation 2.04
|
3.52 score on a scale (describing the units)
Standard Deviation 1.77
|
|
Fatigue Interference
Week 8
|
2.73 score on a scale (describing the units)
Standard Deviation 2.10
|
2.43 score on a scale (describing the units)
Standard Deviation 1.34
|
|
Fatigue Interference
Week 12
|
2.96 score on a scale (describing the units)
Standard Deviation 2.06
|
1.32 score on a scale (describing the units)
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksThe Fatigue Symptom Inventory (FSI), is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. Severity is measured on separate 11-point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured as the number of days in the past week (0-7) that respondents felt fatigued as well as the extent of each day on average they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on separate 11-point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue in the past week was judged to interfere with general level of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Higher FSI scores are associated with worse outcomes.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Fatigue Severity
Baseline
|
5.03 units on a scale
Standard Deviation 1.21
|
5.05 units on a scale
Standard Deviation 0.91
|
|
Fatigue Severity
Week 4
|
3.88 units on a scale
Standard Deviation 1.55
|
4.36 units on a scale
Standard Deviation 1.43
|
|
Fatigue Severity
Week 8
|
4.06 units on a scale
Standard Deviation 1.75
|
4.16 units on a scale
Standard Deviation 1.25
|
|
Fatigue Severity
Week 12
|
4.22 units on a scale
Standard Deviation 1.81
|
3.33 units on a scale
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksThe Fatigue Symptom Inventory (FSI), is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. Severity is measured on separate 11-point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured as the number of days in the past week (0-7) that respondents felt fatigued as well as the extent of each day on average they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on separate 11-point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue in the past week was judged to interfere with general level of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Higher FSI scores are associated with worse outcomes.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Current Fatigue
Baseline
|
4.52 units on a scale
Standard Deviation 2.31
|
4.52 units on a scale
Standard Deviation 1.57
|
|
Current Fatigue
Week 4
|
3.48 units on a scale
Standard Deviation 2.23
|
4.33 units on a scale
Standard Deviation 2.32
|
|
Current Fatigue
Week 8
|
4.04 units on a scale
Standard Deviation 2.50
|
4.00 units on a scale
Standard Deviation 2.00
|
|
Current Fatigue
Week 12
|
4.17 units on a scale
Standard Deviation 2.67
|
2.73 units on a scale
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksEmotional distress was assessed using the Generalized Anxiety Disorder 7-Item (GAD-7), which is a reliable and validated self-report measure to assess anxiety symptoms. For the GAD-7, respondents rated how often they have been bothered by 7 anxiety symptoms over the past 2 weeks using the following scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every day. Respondents also answer a question to assess the duration of their anxiety symptoms. The scale is scored 0-21, where 0-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and scores \>15 is severe anxiety. Using a cut-off of 8 the GAD-7 has a sensitivity of 92% and specificity of 76% for diagnosis generalized anxiety disorder.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Emotional Distress: Anxiety Symptoms
Baseline
|
5.84 score on a scale (describing the units)
Standard Deviation 4.88
|
5.85 score on a scale (describing the units)
Standard Deviation 4.75
|
|
Emotional Distress: Anxiety Symptoms
Week 4
|
5.51 score on a scale (describing the units)
Standard Deviation 4.50
|
4.12 score on a scale (describing the units)
Standard Deviation 2.71
|
|
Emotional Distress: Anxiety Symptoms
Week 8
|
6.14 score on a scale (describing the units)
Standard Deviation 5.34
|
3.94 score on a scale (describing the units)
Standard Deviation 3.36
|
|
Emotional Distress: Anxiety Symptoms
Week 12
|
5.32 score on a scale (describing the units)
Standard Deviation 4.91
|
2.83 score on a scale (describing the units)
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksFear of cancer recurrence will be measured using the 42-item Fear of Cancer Recurrence Inventory (FCRI). This survey has been validated across diverse cancer populations, has strong psychometric qualities, and is the most comprehensive multidimensional scale of FCR available.\[36, 37\] Items are scored on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal or "all the time"). Higher scores indicate higher FCR. The FCRI is both internally consistent (Cronbach's α=0.75 to 0.91 across subscales) and stable over a two-week interval (ρ = 0.58 to 0.83 across subscales). It also has convergent validity with other standardized measures of FCR (ρ = 0.66 to 0.77) and discriminant validity with QOL amongst a large sample (n = 600) of Canadian cancer patients with varying tumor types.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Fear of Cancer Recurrence
Baseline
|
88.2 score on a scale (describing the units)
Standard Deviation 27.2
|
83.6 score on a scale (describing the units)
Standard Deviation 20.2
|
|
Fear of Cancer Recurrence
Week 4
|
81.5 score on a scale (describing the units)
Standard Deviation 27.7
|
72.9 score on a scale (describing the units)
Standard Deviation 19.8
|
|
Fear of Cancer Recurrence
Week 8
|
81.0 score on a scale (describing the units)
Standard Deviation 30.4
|
74.0 score on a scale (describing the units)
Standard Deviation 23.0
|
|
Fear of Cancer Recurrence
Week 12
|
78.6 score on a scale (describing the units)
Standard Deviation 26.1
|
66.9 score on a scale (describing the units)
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksParticipants' quality of life (QOL) was assessed with the Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O), which has demonstrated internal consistency, reliability, and validity. This measure is composed of the Functional Assessment of Cancer Therapy-General scale, with an ovarian cancer-specific subscale (OCS) included. The measure is divided into five primary QOL domains: physical well-being (7-items, scored 0-28), social/family well-being (7-items, scored 0-28), emotional well-being (6-items, scored 0-24), functional well-being (7-items, scored 0-28), and additional concerns (OCS subscale, 12-items, scored 0-44). Participants rated each QOL domain item based on the past 7 days as: 0) Not at all; 1) A little bit; 2) Somewhat, 3) Quite a bit, and 4) Very much. Subscales can be analyzed separately or aggregated to produce a total score which is scored 0-152 with higher scores signifying better quality of life.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Participant Quality of Life
Baseline
|
60.39 score on a scale (describing the units)
Standard Deviation 12.70
|
60.76 score on a scale (describing the units)
Standard Deviation 11.43
|
|
Participant Quality of Life
Week 4
|
64.09 score on a scale (describing the units)
Standard Deviation 14.10
|
64.15 score on a scale (describing the units)
Standard Deviation 12.05
|
|
Participant Quality of Life
Week 8
|
63.30 score on a scale (describing the units)
Standard Deviation 15.01
|
66.37 score on a scale (describing the units)
Standard Deviation 12.09
|
|
Participant Quality of Life
Week 12
|
61.63 score on a scale (describing the units)
Standard Deviation 14.60
|
69.81 score on a scale (describing the units)
Standard Deviation 11.01
|
SECONDARY outcome
Timeframe: Change from baseline to 4-weeks, 8-weeks, and 12-weeksWe assessed emotional distress with the 8-item Patient Health Questionnaire (PHQ-8), which is a reliable and validated self-report measure to assess depressive symptoms. For the PHQ-8, respondents rated how often they have been bothered by 8 symptoms of depression over the past 2 weeks using the following scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every day. The scale is totaled (range 0-24) where total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Emotional Distress: Depressive Symptoms
Baseline
|
7.14 score on a scale (describing the units)
Standard Deviation 4.05
|
7.14 score on a scale (describing the units)
Standard Deviation 3.88
|
|
Emotional Distress: Depressive Symptoms
4 weeks
|
6.17 score on a scale (describing the units)
Standard Deviation 4.66
|
4.60 score on a scale (describing the units)
Standard Deviation 2.41
|
|
Emotional Distress: Depressive Symptoms
8 weeks
|
6.13 score on a scale (describing the units)
Standard Deviation 4.24
|
4.27 score on a scale (describing the units)
Standard Deviation 2.02
|
|
Emotional Distress: Depressive Symptoms
12 weeks
|
6.13 score on a scale (describing the units)
Standard Deviation 4.24
|
3.98 score on a scale (describing the units)
Standard Deviation 2.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 12-weeksWe examined the number of participants who required reductions in the dose of their PARP inhibitor during the trial.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=21 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=15 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Adherence
Dose reduction
|
4 Participants
|
1 Participants
|
|
Adherence
No dose reduction
|
17 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksWe assessed participants tendency to catastrophize about their fatigue using the Fatigue Catastrophizing Survey (FCS). Patients rate each question on a 5-point scale (1=never true to 5=all of the time) to indicate how often each item is true for them when they've experienced fatigue. The scale is scored by totaling the 10 items (range 10-50, where higher scores mean more severe fatigue catastrophizing). In prior research, more catastrophizing (as indicated by higher scores on the FCS) were associated with significantly greater fatigue.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Catastrophizing
Baseline
|
19.07 score on a scale (describing the units)
Standard Deviation 8.86
|
17.58 score on a scale (describing the units)
Standard Deviation 7.13
|
|
Catastrophizing
Week 4
|
17.35 score on a scale (describing the units)
Standard Deviation 5.62
|
15.09 score on a scale (describing the units)
Standard Deviation 4.01
|
|
Catastrophizing
Week 8
|
17.71 score on a scale (describing the units)
Standard Deviation 6.76
|
15.33 score on a scale (describing the units)
Standard Deviation 4.62
|
|
Catastrophizing
Week 12
|
17.57 score on a scale (describing the units)
Standard Deviation 6.11
|
13.20 score on a scale (describing the units)
Standard Deviation 2.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksSelf-efficacy concerning fatigue (i.e. the belief in one's capabilities to execute behaviors) was measured with the 7-item Self-Efficacy Scale (SES28). Items are scored on a 4-point Likert scale, and total scores range from 4 to 28. Higher scores indicate a greater sense of control over fatigue.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Fatigue Self-Efficacy
Baseline
|
19.48 score on a scale (describing the units)
Standard Deviation 3.22
|
19.90 score on a scale (describing the units)
Standard Deviation 2.19
|
|
Fatigue Self-Efficacy
Week 4
|
20.39 score on a scale (describing the units)
Standard Deviation 3.2
|
21.73 score on a scale (describing the units)
Standard Deviation 2.66
|
|
Fatigue Self-Efficacy
Week 8
|
19.74 score on a scale (describing the units)
Standard Deviation 3.26
|
21.93 score on a scale (describing the units)
Standard Deviation 3.13
|
|
Fatigue Self-Efficacy
Week 12
|
20.09 score on a scale (describing the units)
Standard Deviation 3.50
|
22.27 score on a scale (describing the units)
Standard Deviation 2.84
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OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksWe will measure changes in psychological flexibility (ACT processes) using the Acceptance and Action Cancer questionnaire, which is a 18-item measure adapted from the widely validated AAQ-II and diabetes-adapted AAQ towards cancer specific items. Numerous adaptations of the AAQ towards specific clinical targets have been shown to produce valid measures that mediate ACT outcomes for the specific population. The scale is scored by totaling the individual items (scale: 18-126). Lower scores reflect more psychological flexibility.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Psychological Flexibility
Baseline
|
51.11 score on a scale (describing the units)
Standard Deviation 18.23
|
48.26 score on a scale (describing the units)
Standard Deviation 16.06
|
|
Psychological Flexibility
4 weeks
|
49.25 score on a scale (describing the units)
Standard Deviation 18.11
|
41.56 score on a scale (describing the units)
Standard Deviation 16.62
|
|
Psychological Flexibility
8 weeks
|
47.64 score on a scale (describing the units)
Standard Deviation 20.68
|
43.12 score on a scale (describing the units)
Standard Deviation 16.30
|
|
Psychological Flexibility
12 weeks
|
49.08 score on a scale (describing the units)
Standard Deviation 18.26
|
36.31 score on a scale (describing the units)
Standard Deviation 10.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksExperiential avoidance will be measured using the Brief Multidimensional Experiential Avoidance Questionnaire (BEAQ) which only includes 15-items and covers all dimensions of experiential avoidance, including: behavioral avoidance, distress aversion, procrastination, distraction and suppression, repression and denial, and distress endurance. The scale is scored by totaling individual items (range 15-90), where higher scores reflect more avoidance. This measure is internally consistent and has been broadly associated with psychopathology and quality of life.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Experiential Avoidance
Baseline
|
40.17 score on a scale (describing the units)
Standard Deviation 9.57
|
40.90 score on a scale (describing the units)
Standard Deviation 13.43
|
|
Experiential Avoidance
4 weeks
|
40.26 score on a scale (describing the units)
Standard Deviation 11.43
|
35.80 score on a scale (describing the units)
Standard Deviation 11.49
|
|
Experiential Avoidance
8 weeks
|
39.64 score on a scale (describing the units)
Standard Deviation 9.62
|
36.08 score on a scale (describing the units)
Standard Deviation 12.07
|
|
Experiential Avoidance
12 weeks
|
41.41 score on a scale (describing the units)
Standard Deviation 11.61
|
33.40 score on a scale (describing the units)
Standard Deviation 12.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksWe will use the 10-item Valuing Questionnaire (VQ) to assess personal values enactment during the past two weeks. Respondents rate on a 6 point scale (0 "not at all true" to 6 "completely true") how often each item was true for them during the past two weeks and evaluate using a two-factor scale; the Progress scale and Obstruction scale. The scale is scored by totaling 5 individual items (scored 0-30), where higher progress scores are associated with positive affect, satisfaction with life, purpose in life and mastery and self-acceptance.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Value: Progress
Baseline
|
22.91 score on a scale (describing the units)
Standard Deviation 5.14
|
23.93 score on a scale (describing the units)
Standard Deviation 4.61
|
|
Value: Progress
4 weeks
|
20.78 score on a scale (describing the units)
Standard Deviation 7.15
|
23.28 score on a scale (describing the units)
Standard Deviation 5.97
|
|
Value: Progress
8 weeks
|
22.67 score on a scale (describing the units)
Standard Deviation 6.26
|
26.00 score on a scale (describing the units)
Standard Deviation 4.00
|
|
Value: Progress
12 weeks
|
23.00 score on a scale (describing the units)
Standard Deviation 5.16
|
25.27 score on a scale (describing the units)
Standard Deviation 5.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 4-, 8-, and 12-weeksWe will use the 10-item Valuing Questionnaire (VQ) to assess personal values enactment during the past two weeks. Respondents rate on a 6 point scale (0 "not at all true" to 6 "completely true") how often each item was true for them during the past two weeks and evaluate using a two-factor scale; the Progress scale and Obstruction scale. The VQ Obstruction subscale is scored by totaling the sum of 5 items (scored 0-30) Higher VQ Obstruction scores are associated with more depressive symptoms and negative affect.
Outcome measures
| Measure |
Enhanced Usual Care (EUC)
n=23 Participants
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
|
REVITALIZE ACT Intervention
n=21 Participants
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
|
|---|---|---|
|
Valuing: Obstruction
Baseline
|
11.72 score on a scale (describing the units)
Standard Deviation 5.03
|
11.93 score on a scale (describing the units)
Standard Deviation 4.75
|
|
Valuing: Obstruction
4 weeks
|
11.26 score on a scale (describing the units)
Standard Deviation 5.45
|
10.47 score on a scale (describing the units)
Standard Deviation 4.37
|
|
Valuing: Obstruction
8 weeks
|
10.35 score on a scale (describing the units)
Standard Deviation 5.12
|
8.93 score on a scale (describing the units)
Standard Deviation 4.43
|
|
Valuing: Obstruction
12 weeks
|
12.13 score on a scale (describing the units)
Standard Deviation 5.47
|
9.87 score on a scale (describing the units)
Standard Deviation 4.49
|
Adverse Events
Enhanced Usual Care (EUC)
REVITALIZE ACT Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place