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临床试验/NCT05905250
NCT05905250已完成不适用

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

George Washington University1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
1
主要终点
Retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Intervention

Experimental

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.

干预措施: an empirically supported protocol, further refined with evidence-based strategies (Behavioral)

Attention Control

Active Comparator

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

干预措施: Health education (Behavioral)

结局指标

主要结局

Retention

时间窗: 4 months (follow-up; FU)

Number of Participants with Retention at End of Study

Adherence

时间窗: 2 months (end-of-treatment; EOT)

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

Acceptability

时间窗: 2 months (end-of-treatment; EOT)

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

Hope

时间窗: 4 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).

Retention

时间窗: 2 months (end-of-treatment; EOT)

Number of Participants with Retention at End of Treatment

次要结局

  • Hope(2 months (end-of-treatment; EOT))
  • Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale(4 months (follow-up; FU))
  • Functional Assessment of Cancer Therapy - General (FACT-G)(4 months (follow-up; FU))
  • Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale(2 months (end-of-treatment; EOT))
  • Functional Assessment of Cancer Therapy - General (FACT-G)(2 months (end-of-treatment; EOT))
  • Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)(2 months (end-of-treatment; EOT))
  • Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)(4 months (follow-up; FU))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Berg

Professor of Prevention and Community Health

George Washington University

研究点 (1)

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