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mHealth for Young Adult Cancer Survivors

An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05905250
Acronym
mHealthAYA
Enrollment
155
Registered
2023-06-15
Start date
2024-03-15
Completion date
2025-02-28
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Psychological Well-Being, Survivorship

Brief summary

We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.

Detailed description

Young adulthood (YA) is a critical time in shaping life trajectories related to educational, financial, and family goals, among others. Unfortunately, cancer diagnosis/treatment and its psychosocial sequelae disrupt this critical period for some YAs. This life goal disturbance is related to poorer psychological outcomes, particularly among YAs; however, goal revision and reprioritization lead to more positive psychological outcomes. Thus, goal negotiation is a critical part of survivorship. Understanding psychosocial determinants of positive psychological and behavioral outcomes is critical for developing effective behavioral interventions. Within the rich positive psychology literature, the construct of hope is one particularly relevant factor for YA cancer survivors; hope has been defined as a positive cognitive state based on a sense of successful goal-directed determination and planning to meet these goals. In the general population and in cancer survivors, hope is related to better quality of life (QOL), mental health, health behaviors, and coping with illness/cancer. Our team pioneered an mHealth intervention (i.e., app-based with phone-based counseling) aimed at increasing hope among YA survivors, thereby re-engaging them in long-term life goals across domains (e.g., vocational, familial) and ultimately increasing QOL. In an 8-week pilot randomized controlled trial (RCT) of 56 YAs recruited from 2 cancer centers, the intervention demonstrated feasibility (95% retention), acceptability (e.g., high satisfaction), and promising trends in changes in hope, QOL, depressive symptoms, and health behaviors (e.g., substance use) in YA survivors. This study builds on our prior work to update the intervention (e.g., its technology), enhance its reach, and increase our ability to examine its effects. Our specific aims are to: 1) conduct formative research examining YA cancer survivor preferences on phone-based counseling with app support to enhance the intervention; and 2) test the feasibility, acceptability, and preliminary efficacy of the intervention vs. attention control (AC) via an 8-week RCT of 150 YA cancer survivors. The proposed research is innovative in its use of a novel intervention target - hope - as a mechanism for addressing goal-disruption and QOL among YA survivors, and its use of novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare.

Interventions

BEHAVIORALan empirically supported protocol, further refined with evidence-based strategies

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.

BEHAVIORALHealth education

Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.

Sponsors

George Washington University
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The investigative team will be masked except in the event interventionists or data collectors require input from the team that requires disclosure of identifying information. Participants will be randomized to the intervention or attention control.

Intervention model description

Individual randomized control trial with 1:1 randomization

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of stage I-IV cancer from age 18-39 * Completion of curative treatment (surgery, chemotherapy and/or radiation) within three years of study enrollment * No significant psychological disabilities * Able to complete forms and understand instructions in English * Smartphone access * Aim 2: Able to commit to 8-week remotely delivered study

Exclusion criteria

* Completion of curative treatment (surgery, chemotherapy and/or radiation) over three years ago or currently in treatment * Significant psychological disabilities

Design outcomes

Primary

MeasureTime frameDescription
Retention2 months (end-of-treatment; EOT)Number of Participants with Retention at End of Treatment
Adherence2 months (end-of-treatment; EOT)Adherence to intervention (number of sessions completed out of 8)
Acceptability2 months (end-of-treatment; EOT)\>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)
Hope4 months (follow-up; FU)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).

Secondary

MeasureTime frameDescription
Hope2 months (end-of-treatment; EOT)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).
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale2 months (end-of-treatment; EOT)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)
Functional Assessment of Cancer Therapy - General (FACT-G)2 months (end-of-treatment; EOT)Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)2 months (end-of-treatment; EOT)Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)4 months (follow-up; FU)Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarla J Berg, PhD

George Washington University

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
78
Attention Control
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
77
Total155

Baseline characteristics

CharacteristicTotalAttention ControlIntervention
Age, Continuous32.89 Years
STANDARD_DEVIATION 4.86
32.82 Years
STANDARD_DEVIATION 4.79
32.96 Years
STANDARD_DEVIATION 5.01
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants4 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
142 Participants73 Participants69 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hope49.41 units on a scale
STANDARD_DEVIATION 8.55
50.09 units on a scale
STANDARD_DEVIATION 8.03
48.74 units on a scale
STANDARD_DEVIATION 9.03
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
15 Participants8 Participants7 Participants
Race (NIH/OMB)
Black or African American
10 Participants4 Participants6 Participants
Race (NIH/OMB)
More than one race
9 Participants3 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
120 Participants62 Participants58 Participants
Region of Enrollment
United States
155 Participants77 Participants78 Participants
Sex: Female, Male
Female
136 Participants67 Participants69 Participants
Sex: Female, Male
Male
19 Participants10 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 780 / 77
other
Total, other adverse events
0 / 780 / 77
serious
Total, serious adverse events
0 / 780 / 77

Outcome results

Primary

Acceptability

\>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)

Time frame: 2 months (end-of-treatment; EOT)

Population: Analyzed among participants who completed the 2-month survey

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionAcceptability57 Participants
Attention ControlAcceptability43 Participants
Primary

Acceptability

\>75% report yes to would you recommend this program to your friends who are cancer survivors?

Time frame: 2 months (end-of-treatment; EOT)

Population: Analyzed among participants who completed the 2-month survey

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionAcceptability67 Participants
Attention ControlAcceptability60 Participants
Primary

Adherence

Adherence to intervention (number of sessions completed out of 8)

Time frame: 2 months (end-of-treatment; EOT)

ArmMeasureValue (MEAN)Dispersion
InterventionAdherence7.0 Number of sessionsStandard Deviation 2
Attention ControlAdherence7.3 Number of sessionsStandard Deviation 1.8
Primary

Hope

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).

Time frame: 4 months (follow-up; FU)

Population: Analyzed among participants who completed the 4-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionHope50.15 Scores on a scaleStandard Deviation 7.94
Attention ControlHope51.11 Scores on a scaleStandard Deviation 8.35
Primary

Retention

Number of Participants with Retention at End of Treatment

Time frame: 2 months (end-of-treatment; EOT)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionRetention74 Participants
Attention ControlRetention72 Participants
Primary

Retention

Number of Participants with Retention at End of Study

Time frame: 4 months (follow-up; FU)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionRetention75 Participants
Attention ControlRetention72 Participants
Secondary

Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)

Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales

Time frame: 2 months (end-of-treatment; EOT)

Population: Analyzed among participants who completed the 2-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionDepression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)53.62 Scores on a scaleStandard Deviation 8.69
Attention ControlDepression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)52.68 Scores on a scaleStandard Deviation 7.9
Secondary

Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)

Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales

Time frame: 4 months (follow-up; FU)

Population: Analyzed among participants who completed the 4-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionDepression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)52.05 Scores on a scaleStandard Deviation 8.71
Attention ControlDepression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)53.04 Scores on a scaleStandard Deviation 8.13
Secondary

Functional Assessment of Cancer Therapy - General (FACT-G)

Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)

Time frame: 2 months (end-of-treatment; EOT)

Population: Analyzed among participants who completed the 2-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionFunctional Assessment of Cancer Therapy - General (FACT-G)77.49 Scores on a scaleStandard Deviation 17.52
Attention ControlFunctional Assessment of Cancer Therapy - General (FACT-G)80.17 Scores on a scaleStandard Deviation 15.87
Secondary

Functional Assessment of Cancer Therapy - General (FACT-G)

Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)

Time frame: 4 months (follow-up; FU)

Population: Analyzed among participants who completed the 4-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionFunctional Assessment of Cancer Therapy - General (FACT-G)79.18 Scores on a scaleStandard Deviation 11.37
Attention ControlFunctional Assessment of Cancer Therapy - General (FACT-G)79.15 Scores on a scaleStandard Deviation 10.41
Secondary

Hope

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).

Time frame: 2 months (end-of-treatment; EOT)

Population: Analyzed among participants who completed the 2-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionHope50.78 Scores on a scaleStandard Deviation 8.32
Attention ControlHope49.82 Scores on a scaleStandard Deviation 8.6
Secondary

Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale

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)

Time frame: 2 months (end-of-treatment; EOT)

Population: Analyzed among participants who completed the 2-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionQuality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale51.72 Scores on a scaleStandard Deviation 3.75
Attention ControlQuality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale51.38 Scores on a scaleStandard Deviation 3.4
Secondary

Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale

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)

Time frame: 4 months (follow-up; FU)

Population: Analyzed among participants who completed the 4-month survey

ArmMeasureValue (MEAN)Dispersion
InterventionQuality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale51.17 Scores on a scaleStandard Deviation 3.5
Attention ControlQuality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale51.56 Scores on a scaleStandard Deviation 3.1

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026