CancerNCT03446105
Promoting Quality of Life Among Young Adult Cancer Survivors
A study testing App-based behavioral intervention in people with Cancer, run by Emory University at 2 sites in United States.
Trial summary
This study expands on a prior pilot study to refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the intervention to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two National Cancer Institute (NCI)-designated cancer centers (Emory's… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- App-based behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 39, as of January 15th, 2017
- Speak English
- Be within two years of cancer treatment completion (since January 15th, 2015)
- Have a functioning smartphone and reliable internet access
- Be willing to complete study activities
Who cannot join
- Cancer recurrence since treatment completion
- Diagnosis of a central nervous system cancer (to ensure requisite mental/emotional functioning to engage in the program)
- Diagnosis of a thyroid cancer
- History of alcohol or drug dependency in the past year, or psychosis, bipolar disorder, or major depressive disorder
- In hospice
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Markey Cancer Center
Lexington, Kentucky, 40536
About this study
This study expands on a prior pilot study to refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the intervention to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two National Cancer Institute (NCI)-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). Participants will be randomly assigned (stratified by age and sex) to one of the 8-week treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).
Read the detailed description
Young adulthood is a critical time for negotiating several life transitions and establishing and pursuing important life goals. Unfortunately, a cancer diagnosis disrupts this period of life for more than 60,000 people annually in the U.S. Compared to those without a history of cancer, young adult cancer survivors report poorer mental and physical health; moreover, they report significantly greater disruption in their goal pursuits than cancer survivors diagnosed at a later age. However, this high-risk group has been underserved and understudied, particularly in terms of intervention research to address these sequelae. Hope, a positive psychology construct that taps the ways in which people choose and pursue goals, is particularly relevant to this population. Additionally, higher hope is related to engaging in health promoting behaviors and living healthier lifestyles, which reduces risk of disease and adverse late effects and ultimately increase quality of life (QOL). The research team has pioneered a app-based behavioral intervention called Achieving Wellness After Kancer in Early life (AWAKE), aimed at promoting healthy lifestyles - specifically targeting mental health and positive health behaviors - among young adult cancer survivors. The proposed study will refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the prior pilot work to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two NCI-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). In this randomized controlled trial, recipients of the AWAKE intervention will be compared to an attention control group.
The specific aims of this study are to:
Aim 1. Test the feasibility and acceptability of AWAKE among intervention participants. The primary feasibility indicators are participation rates and retention rates. The primary acceptability indicators are use of and satisfaction with intervention components.
Aim 2. Estimate effect sizes of AWAKE vs. control at 2 and 6 months to inform sample size calculations for the subsequent efficacy trial. The primary outcome is changes in hope, per the Trait Hope Scale. The secondary outcome is changes in quality of life, per the 36-Item Short Form Health Survey (SF-36) and the Functional Assessment of Cancer Therapy - General (FACT-G).
- Conditions
- Cancer
- Being tested
- App-based behavioral intervention, Attention control group
- Keywords
- Cancer survivor, App-based intervention, Behavioral intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based behavioral interventionBehavioural
Also called AWAKE
Achieving Wellness After Kancer in Early life (AWAKE) is a behavioral intervention that includes a smartphone app and coaching. AWAKE contains eight modules, and participants will complete the one module every week. App functioning will facilitate weekly homework assignments and include health education messaging, the ability to track progress toward goals over time via self-monitoring and graphical depictions of progress, audio-recordings of guided imagery exercises and relaxation exercises (e.g., progressive muscle relaxation), videos of topic-related inspirational material, and a portal for interacting with the coach. The coach will call each intervention participant weekly. Each coaching session will last roughly 30 minutes and involve four segments that will correspond to the module for the week. The coach will send daily text messages to participants encouraging their goal pursuits and providing other sources of support related to that week's homework.
Attention control groupBehavioural
The attention control group will receive the same components as the intervention group, but the educational modules will contain different content than those receiving the AWAKE intervention.
| Study group | Role | What they receive |
|---|---|---|
| App-based behavioral intervention | Experimental | Participants randomized to this study arm will take part in the Achieving Wellness After Kancer in Early life (AWAKE) behavioral intervention for 8 weeks. Receives: Behavioral: App-based behavioral intervention |
| Attention control group | Active comparator | Participants randomized to this study arm will take part in a behavioral intervention and coaching for 8 weeks. Receives: Behavioral: Attention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult Trait Hope Scale Score
The Adult Trait Hope Scale is a 12-item survey where respondents indicate how true a statement is on a scale of 1 (definitely false) to 8 (definitely true). The Hope Scale includes two subscales of four items each plus four distracter items. Higher scores on the Pathways subscale (example question: "I can think of many ways to get out of a jam") indicate higher levels of pathways thinking. Higher scores on the Agency subscale (example question: "I energetically pursue my goals") indicate higher levels of agency thinking. The subscales will be summed to obtain a total hope score. Total scores can range from 8 to 64 with higher scores indicating higher levels of hope.
Measured: Baseline, Month 2, Month 6
Secondary outcomes (2)
Change in 36-Item Short Form Health Survey (SF-36) Score
The 36-Item Short-Form Health Survey (SF-36) asks respondents to rate their health and abilities to do their usual tasks. The SF-36 uses a variety of questions and response options and includes 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health). Responses are coded on a scale of 0 to 100 where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed and averaged to obtain a mean score for the entire survey.
The SF-36 is standardized to the general population with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better than average health while scores below 50 are worse than average health scores.
Measured: Baseline, Month 2, Month 6
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
The FACT-G is a 27-item quality of life (QOL) measure specific to cancer patients to provide insight into cancer specific factors in four dimensions (physical, social/family, emotional, functional well-being). Participants respond to a list of statements that tend to impact people with cancer by indicating how much they are impacted on a scale of 0 (not at all) to 4 (very much). Scores for negatively worded statements are reversed so that higher scores indicate positive health. Scores from the four dimensions can be summed to create a total score. Total possible scores range from 0 to 108, with higher scores indicating increased well being.
Measured: Baseline, Month 2, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start9 Feb 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned (stratified by age and sex) to one of the treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Berg, Emory University
- Investigators
- Carla Berg, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446105
- Sponsor's protocol ID
- IRB00086979
- Status last verified
- Aug 2018
- First submitted
- 21 Feb 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Quality of Life Among Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT03446105
- Acronym / sponsor ID
- IRB00086979
- Conditions
- Cancer
- Keywords
- Cancer survivor, App-based intervention, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study expands on a prior pilot study to refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the intervention to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two National Cancer Institute (NCI)-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). Participants will be randomly assigned (stratified by age and sex) to one of the 8-week treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).
Detailed description
Young adulthood is a critical time for negotiating several life transitions and establishing and pursuing important life goals. Unfortunately, a cancer diagnosis disrupts this period of life for more than 60,000 people annually in the U.S. Compared to those without a history of cancer, young adult cancer survivors report poorer mental and physical health; moreover, they report significantly greater disruption in their goal pursuits than cancer survivors diagnosed at a later age. However, this high-risk group has been underserved and understudied, particularly in terms of intervention research to address these sequelae. Hope, a positive psychology construct that taps the ways in which people choose and pursue goals, is particularly relevant to this population. Additionally, higher hope is related to engaging in health promoting behaviors and living healthier lifestyles, which reduces risk of disease and adverse late effects and ultimately increase quality of life (QOL). The research team has pioneered a app-based behavioral intervention called Achieving Wellness After Kancer in Early life (AWAKE), aimed at promoting healthy lifestyles - specifically targeting mental health and positive health behaviors - among young adult cancer survivors. The proposed study will refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the prior pilot work to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two NCI-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). In this randomized controlled trial, recipients of the AWAKE intervention will be compared to an attention control group.
The specific aims of this study are to:
Aim 1. Test the feasibility and acceptability of AWAKE among intervention participants. The primary feasibility indicators are participation rates and retention rates. The primary acceptability indicators are use of and satisfaction with intervention components.
Aim 2. Estimate effect sizes of AWAKE vs. control at 2 and 6 months to inform sample size calculations for the subsequent efficacy trial. The primary outcome is changes in hope, per the Trait Hope Scale. The secondary outcome is changes in quality of life, per the 36-Item Short Form Health Survey (SF-36) and the Functional Assessment of Cancer Therapy - General (FACT-G).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned (stratified by age and sex) to one of the treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).
| Arm | Type | Receives |
|---|---|---|
| App-based behavioral intervention | Experimental | Behavioral: App-based behavioral interventionParticipants randomized to this study arm will take part in the Achieving Wellness After Kancer in Early life (AWAKE) behavioral intervention for 8 weeks. |
| Attention control group | Active comparator | Behavioral: Attention control groupParticipants randomized to this study arm will take part in a behavioral intervention and coaching for 8 weeks. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 39, as of January 15th, 2017
- Speak English
- Be within two years of cancer treatment completion (since January 15th, 2015)
- Have a functioning smartphone and reliable internet access
- Be willing to complete study activities
Key exclusion criteria (5 listed)
- Cancer recurrence since treatment completion
- Diagnosis of a central nervous system cancer (to ensure requisite mental/emotional functioning to engage in the program)
- Diagnosis of a thyroid cancer
- History of alcohol or drug dependency in the past year, or psychosis, bipolar disorder, or major depressive disorder
- In hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based behavioral interventionAlso: AWAKEAchieving Wellness After Kancer in Early life (AWAKE) is a behavioral intervention that includes a smartphone app and coaching. AWAKE contains eight modules, and participants will complete the one module every week. App functioning will facilitate weekly homework assignments and include health education messaging, the ability to track progress toward goals over time via self-monitoring and graphical depictions of progress, audio-recordings of guided imagery exercises and relaxation exercises (e.g., progressive muscle relaxation), videos of topic-related inspirational material, and a portal for interacting with the coach. The coach will call each intervention participant weekly. Each coaching session will last roughly 30 minutes and involve four segments that will correspond to the module for the week. The coach will send daily text messages to participants encouraging their goal pursuits and providing other sources of support related to that week's homework. | Behavioural | App-based behavioral intervention |
| Attention control groupThe attention control group will receive the same components as the intervention group, but the educational modules will contain different content than those receiving the AWAKE intervention. | Behavioural | Attention control group |
Primary outcome
Change in Adult Trait Hope Scale Score
Time frame: Baseline, Month 2, Month 6
The Adult Trait Hope Scale is a 12-item survey where respondents indicate how true a statement is on a scale of 1 (definitely false) to 8 (definitely true). The Hope Scale includes two subscales of four items each plus four distracter items. Higher scores on the Pathways subscale (example question: "I can think of many ways to get out of a jam") indicate higher levels of pathways thinking. Higher scores on the Agency subscale (example question: "I energetically pursue my goals") indicate higher levels of agency thinking. The subscales will be summed to obtain a total hope score. Total scores can range from 8 to 64 with higher scores indicating higher levels of hope.
2 secondary outcomes
Change in 36-Item Short Form Health Survey (SF-36) Score
Time frame: Baseline, Month 2, Month 6
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
Time frame: Baseline, Month 2, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Berg, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based behavioral intervention in people with Cancer, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adult Trait Hope Scale Score (time frame: Baseline, Month 2, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.