- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03446105
Promoting Quality of Life Among Young Adult Cancer Survivors
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Winship Cancer Institute
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40536
- Markey Cancer Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: App-based behavioral intervention
Participants randomized to this study arm will take part in the Achieving Wellness After Kancer in Early life (AWAKE) behavioral intervention for 8 weeks.
|
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.
Andere namen:
|
Actieve vergelijker: Attention control group
Participants randomized to this study arm will take part in a behavioral intervention and coaching for 8 weeks.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Adult Trait Hope Scale Score
Tijdsspanne: 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.
|
Baseline, Month 2, Month 6
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in 36-Item Short Form Health Survey (SF-36) Score
Tijdsspanne: Baseline, Month 2, Month 6
|
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. |
Baseline, Month 2, Month 6
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
Tijdsspanne: Baseline, Month 2, Month 6
|
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.
|
Baseline, Month 2, Month 6
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Participation rate
Tijdsspanne: Baseline
|
The participation rate will be recorded to assess feasibility of the intervention.
|
Baseline
|
Retention rate
Tijdsspanne: Month 2, Month 6
|
The retention rate will be recorded to assess feasibility of the intervention.
|
Month 2, Month 6
|
Use of AWAKE
Tijdsspanne: Month 2
|
Acceptability will be assessed by evaluating the number of participants in the intervention who use the AWAKE app.
Participants will be asked about use of specific components of the app, such as watching the videos, recording health behaviors and mood, and completing homework.
|
Month 2
|
Satisfaction with AWAKE
Tijdsspanne: Month 2
|
Participants randomized to AWAKE will receive a survey to assess their satisfaction with the intervention.
Participants will indicate the usefulness of the different components of the AWAKE program as well as overall satisfaction with the program.
|
Month 2
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Carla Berg, PhD, Emory University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- IRB00086979
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Kanker
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)WervingAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
Klinische onderzoeken op App-based behavioral intervention
-
Drexel UniversityVoltooidObesitas | OvergewichtVerenigde Staten
-
University of SurreySurrey and Borders Partnership NHS Foundation TrustWervingAanhoudende depressieve stoornisVerenigd Koninkrijk
-
Stockholm UniversityKarolinska Institutet; Region Stockholm; Centrum för kompetensutveckling inom vård... en andere medewerkersActief, niet wervend
-
University of VermontVoltooid
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...Voltooid
-
University of Nevada, Las VegasNog niet aan het werven
-
Gaziantep Islam Science and Technology UniversityVoltooidStressstoornissen, posttraumatisch | Hemodialyse Complicatie | Psychosociale stoornis | ZelfverwaarlozingKalkoen
-
Instituto de Investigación Hospital Universitario...Universidad Autonoma de MadridVoltooid
-
University of OklahomaThe University of Texas Health Science Center, Houston; National Institute on... en andere medewerkersVoltooidStoornissen in het gebruik van middelen | Gezondheidsgedrag | Aanhankelijkheid, patiënt | Geestelijke gezondheidsstoornisVerenigde Staten