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Promoting Quality of Life Among Young Adult Cancer Survivors

9 agosto 2018 aggiornato da: Carla Berg, Emory University
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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

57

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University Winship Cancer Institute
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536
        • Markey Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 39 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: App-based behavioral intervention
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.
Altri nomi:
  • AWAKE
Comparatore attivo: Attention control group
Participants randomized to this study arm will take part in a behavioral intervention and coaching for 8 weeks.
Comportamentale: Attention control group
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Adult Trait Hope Scale Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in 36-Item Short Form Health Survey (SF-36) Score
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Participation rate
Lasso di tempo: Baseline
The participation rate will be recorded to assess feasibility of the intervention.
Baseline
Retention rate
Lasso di tempo: Month 2, Month 6
The retention rate will be recorded to assess feasibility of the intervention.
Month 2, Month 6
Use of AWAKE
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Emory University

Investigatori

  • Investigatore principale: Carla Berg, PhD, Emory University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 febbraio 2017

Completamento primario (Effettivo)

31 luglio 2018

Completamento dello studio (Effettivo)

31 luglio 2018

Date di iscrizione allo studio

Primo inviato

21 febbraio 2018

Primo inviato che soddisfa i criteri di controllo qualità

21 febbraio 2018

Primo Inserito (Effettivo)

26 febbraio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IRB00086979

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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