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Completed

NCT Number: NCT05048316

Study to Develop a Group-Based E-Health Intervention for YA Cancer Survivors

Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities

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Key information

Conditions

Cancer Survivor Young Adult

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-39 years old
  • Diagnosed with cancer between 18-39 years old
  • Cancer diagnosis was non-metastatic
  • Completed cancer treatment between 1 month and 5 years prior to enrollment, with the exception of ongoing hormone therapy
  • No documented or observable psychiatric or neurological disorders that could interfere with participation (e.g., active psychosis, active substance abuse), as identified by the referring medical team, chart review, or screening
  • Able to speak and read English
  • Able to provide informed consent

Exclusion criteria

  • Metastatic disease
  • Continued cancer treatment
  • Psychiatric or neurological disorders that could interfere with study participation
  • Vulnerable populations will not be included

Treatment and study plan

Cognitive-Behavioral Stress Management and Health Education

Behavioral

Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.

Primary outcomes

  1. Satisfaction assessed by study-specific survey during the intervention - Acceptability

    Time frame: During intervention

    The intervention will be deemed acceptable if, on average, participants report satisfaction with the weekly sessions as ≥2 on a 0-4 scale.

  2. Satisfaction assessed by study-specific survey after the intervention - Acceptability

    Time frame: Immediately after the intervention

    The intervention will be deemed acceptable if, on average, participants report satisfaction with the overall program and intent to continue using the intervention skills as ≥2 on a 0-4 scale.

  3. Session attendance after the intervention - Acceptability

    Time frame: Immediately after the intervention

    Videoconference delivery will be acceptable if average group attendance is ≥6/10 sessions.

Secondary outcomes

  1. Quality of life before intervention

    Time frame: Baseline

    Participants will complete the 27-item Functional Assessment of Cancer Therapy - General

  2. Change in quality of life at after intervention

    Time frame: Immediately after intervention

    Participants will complete the 27-item Functional Assessment of Cancer Therapy - General

Other outcomes

  1. Symptom burden before intervention

    Time frame: Baseline

    Participants will complete the 22-item Impact of Event Scale-Revised

  2. Change in Symptom burden after intervention

    Time frame: Immediately after intervention

    Participants will complete the 22-item Impact of Event Scale-Revised

  3. Cancer-related distress before intervention

    Time frame: Baseline

    Participants will complete the 22-item Impact of Event Scale-Revised

  4. Change in cancer-related distress after intervention

    Time frame: Immediately after intervention

    Participants will complete the 22-item Impact of Event Scale-Revised

  5. Stress management skills self-efficacy before intervention

    Time frame: Baseline

    Participants will complete subscales from the Measure of Current Status

  6. Change in stress management skills self-efficacy after intervention

    Time frame: Immediately after intervention

    Participants will complete subscales from the Measure of Current Status

  7. Coping before intervention

    Time frame: Baseline

    Participants will complete the Brief-COPE

  8. Change in coping after intervention

    Time frame: Immediately after intervention

    Participants will complete the Brief-COPE

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

Pilot Study to Develop a Group-Based E-Health Intervention for Young Adult Cancer Survivors

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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