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Trial Outcomes & Findings for Mind-body Resiliency Intervention for Fear of Cancer Recurrence (NCT NCT04876599)

NCT ID: NCT04876599

Last Updated: 2023-10-12

Results Overview

The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

Baseline to approximately 2 months

Results posted on

2023-10-12

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention (IN FOCUS)
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Overall Study
STARTED
32
32
Overall Study
Follow up Survey #1
31
31
Overall Study
Exit Interview
29
30
Overall Study
Follow up Survey #2
29
29
Overall Study
COMPLETED
28
29
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention (IN FOCUS)
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Overall Study
Missed
2
0
Overall Study
Declined
2
3

Baseline Characteristics

Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention (IN FOCUS)
n=32 Participants
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
n=32 Participants
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Total
n=64 Participants
Total of all reporting groups
Age, Continuous
51.1 Years
STANDARD_DEVIATION 14.7 • n=5 Participants
53.7 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
52.4 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male
Female
26 Participants
n=5 Participants
27 Participants
n=7 Participants
53 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Race/Ethnicity, Customized
Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
White
29 Participants
n=5 Participants
30 Participants
n=7 Participants
59 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to approximately 2 months

The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.

Outcome measures

Outcome measures
Measure
IN FOCUS
n=32 Participants
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
n=32 Participants
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Feasibility: Retention Rate
31 Participants
31 Participants

PRIMARY outcome

Timeframe: Baseline to approximately 2 months

Population: This acceptability metric was assessed within the intervention arm only.

As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention.

Outcome measures

Outcome measures
Measure
IN FOCUS
n=30 Participants
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Enjoyableness
4.33 score on a scale
Standard Deviation .71
—
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Convenience
4.57 score on a scale
Standard Deviation .82
—
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Helpfulness
4.00 score on a scale
Standard Deviation 1.02
—
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Odds of Future Skills Use
4.33 score on a scale
Standard Deviation 1.03
—
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Overall Satisfaction
4.20 score on a scale
Standard Deviation .92
—

SECONDARY outcome

Timeframe: Baseline, approximately 2 months, approximately 5 months

Population: Not all surveys were returned.

Fear of cancer recurrence (FCR) severity will be measured using the 9-item Fear of Cancer Recurrence Inventory severity subscale. Scores range from 0-36 with higher scores indicating greater FCR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FCR.

Outcome measures

Outcome measures
Measure
IN FOCUS
n=32 Participants
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
n=32 Participants
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Fear of Cancer Recurrence
Baseline
23.62 score on a scale
Standard Deviation 4.19
22.22 score on a scale
Standard Deviation 4.88
Fear of Cancer Recurrence
2 Months
19.74 score on a scale
Standard Deviation 4.54
20.90 score on a scale
Standard Deviation 5.34
Fear of Cancer Recurrence
5 Months
20.66 score on a scale
Standard Deviation 5.21
19.27 score on a scale
Standard Deviation 6.08

SECONDARY outcome

Timeframe: Baseline, approximately 2 months, approximately 5 months

Population: Not all surveys were returned.

Resiliency will be measured using the 23-item Current Experiences Scale. Subscale scores and total scores (range from 0-115) will be computed, with higher scores indicating higher resiliency.

Outcome measures

Outcome measures
Measure
IN FOCUS
n=32 Participants
Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. IN FOCUS: Adapted Resiliency Group Intervention
Usual Care
n=32 Participants
Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. Usual Care: Referral to Virtual Group Support
Resiliency
Baseline
71.05 score on a scale
Standard Deviation 14.00
75.23 score on a scale
Standard Deviation 14.05
Resiliency
2 Months
76.24 score on a scale
Standard Deviation 11.89
76.80 score on a scale
Standard Deviation 15.51
Resiliency
5 Months
81.05 score on a scale
Standard Deviation 11.66
75.45 score on a scale
Standard Deviation 16.34

Adverse Events

Intervention (IN FOCUS)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Hall

Massachusetts General Hospital

Phone: ‭+1 (704) 517-7273‬

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place