Trial Outcomes & Findings for mHealth for Young Adult Cancer Survivors (NCT NCT05905250)
NCT ID: NCT05905250
Last Updated: 2025-12-24
Results Overview
Number of Participants with Retention at End of Treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
2 months (end-of-treatment; EOT)
Results posted on
2025-12-24
Participant Flow
This study focuses on young adult (YA) cancer survivors, targeting \~150 participants total enrolled. Inclusion criteria included: 18-39 years old, within 3 years of completing primary treatment or on maintenance chemotherapy, English-speaking, US resident, and smartphone access.
Participants were recruited, screened for eligibility, consented, and asked to complete the baseline survey. Both AWARE and the AC involved an 8-week intervention and control for non-specific intervention components.
Participant milestones
| Measure |
Intervention
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
Attention Control
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
|
Overall Study
COMPLETED
|
78
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mHealth for Young Adult Cancer Survivors
Baseline characteristics by cohort
| Measure |
Intervention
n=78 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
Attention Control
n=77 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.96 Years
STANDARD_DEVIATION 5.01 • n=30 Participants
|
32.82 Years
STANDARD_DEVIATION 4.79 • n=30 Participants
|
32.89 Years
STANDARD_DEVIATION 4.86 • n=60 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=30 Participants
|
67 Participants
n=30 Participants
|
136 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
10 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=30 Participants
|
62 Participants
n=30 Participants
|
120 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=30 Participants
|
73 Participants
n=30 Participants
|
142 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=30 Participants
|
77 Participants
n=30 Participants
|
155 Participants
n=60 Participants
|
|
Hope
|
48.74 units on a scale
STANDARD_DEVIATION 9.03 • n=30 Participants
|
50.09 units on a scale
STANDARD_DEVIATION 8.03 • n=30 Participants
|
49.41 units on a scale
STANDARD_DEVIATION 8.55 • n=60 Participants
|
PRIMARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Number of Participants with Retention at End of Treatment
Outcome measures
| Measure |
Attention Control
n=77 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=78 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Retention
|
72 Participants
Interval 68.0 to 76.0
|
74 Participants
Interval 70.0 to 78.0
|
PRIMARY outcome
Timeframe: 4 months (follow-up; FU)Number of Participants with Retention at End of Study
Outcome measures
| Measure |
Attention Control
n=77 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=78 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Retention
|
72 Participants
|
75 Participants
|
PRIMARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Adherence to intervention (number of sessions completed out of 8)
Outcome measures
| Measure |
Attention Control
n=77 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=78 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Adherence
|
7.3 Number of sessions
Standard Deviation 1.8 • Interval 6.0 to 8.0
|
7.0 Number of sessions
Standard Deviation 2.0 • Interval 6.0 to 8.0
|
PRIMARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Population: Analyzed among participants who completed the 2-month survey
\>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=74 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Acceptability
|
43 Participants
|
57 Participants
|
PRIMARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Population: Analyzed among participants who completed the 2-month survey
\>75% report yes to "would you recommend this program to your friends who are cancer survivors?"
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=74 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Acceptability
|
60 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: 4 months (follow-up; FU)Population: Analyzed among participants who completed the 4-month survey
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=75 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Hope
|
51.11 Scores on a scale
Standard Deviation 8.35
|
50.15 Scores on a scale
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Population: Analyzed among participants who completed the 2-month survey
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
Outcome measures
| Measure |
Attention Control
n=74 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=72 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Hope
|
49.82 Scores on a scale
Standard Deviation 8.60
|
50.78 Scores on a scale
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Population: Analyzed among participants who completed the 2-month survey
Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean scores across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=74 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
|
51.38 Scores on a scale
Standard Deviation 3.40
|
51.72 Scores on a scale
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: 4 months (follow-up; FU)Population: Analyzed among participants who completed the 4-month survey
Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean score across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=75 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
|
51.56 Scores on a scale
Standard Deviation 3.10
|
51.17 Scores on a scale
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: 2 months (end-of-treatment; EOT)Population: Analyzed among participants who completed the 2-month survey
Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=74 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy - General (FACT-G)
|
80.17 Scores on a scale
Standard Deviation 15.87
|
77.49 Scores on a scale
Standard Deviation 17.52
|
SECONDARY outcome
Timeframe: 4 months (follow-up; FU)Population: Analyzed among participants who completed the 4-month survey
Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Outcome measures
| Measure |
Attention Control
n=72 Participants
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
|
Intervention
n=75 Participants
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy - General (FACT-G)
|
79.15 Scores on a scale
Standard Deviation 10.41
|
79.18 Scores on a scale
Standard Deviation 11.37
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place