Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05054569
• Collaborator: American Cancer Society, Inc. (Other)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and pre-test an eHealth group intervention for young adult cancer survivors.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Cognitive-Behavioral Stress Management and Health Education	N/A

Detailed Description

In the first part of this study, the investigators adapted an evidence-based intervention for improving HRQOL to better meet the needs of young adult cancer survivors, and then conducted focus groups with young adult cancer survivors to get feedback on the adapted intervention. In the second part of the study, the investigators will conduct a single-arm pilot trial in which the adapted intervention will be delivered over videoconference via weekly group meetings with a trained facilitator over the course of 10 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Developing and Pre-Testing an eHealth Group Intervention for Young Adult Cancer Survivors
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Dec 15, 2021
• Actual Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10-week eHealth intervention Weekly video conference groups led by a trained facilitator	Behavioral: Cognitive-Behavioral Stress Management and Health Education; 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.

Outcome Measures

Primary Outcome Measures

1. Acceptability of the adapted intervention [Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session]

   Participants will report their satisfaction with individual sessions through brief weekly surveys.

2. Acceptability of the adapted intervention [Over the course of the 10-week intervention, beginning with the first weekly session through the tenth weekly session]

   The number of sessions attended, out of a maximum of 10, will be tracked.

3. Acceptability of the adapted intervention [Immediately after the intervention]

   Immediately after the intervention participants will report their satisfaction with the full program through a brief survey.

Secondary Outcome Measures

1. Change in health-related quality of life (HRQOL) from baseline to immediately after the intervention [Baseline and immediately after the intervention]

   Participants will complete the 27-item Functional Assessment of Cancer Therapy - General. Scores range from 0 to 108, with higher scores reflecting better quality of life.

2. Change in symptom burden from baseline to immediately after the intervention [Baseline and immediately after the intervention]

   Participants will complete a modified version of the Edmonton Symptom Assessment Scale, which assesses 10 common cancer-related symptoms each on a numerical rating scale ranging from 0 to 10. Higher scores indicate greater symptom burden.

3. Change in cancer-related distress from baseline to immediately after the intervention [Baseline and immediately after the intervention]

   Participants will complete the 22-item Impact of Event Scale-Revised. Scores range from 0 to 88, with higher scores indicating greater cancer-related distress.

4. Change in stress management skills self-efficacy from baseline to immediately after the intervention [Baseline and immediately after the intervention]

   Participants will complete subscales from the Measure of Current Status. Subscale scores range from 0 to 8, 0 to 12, or 0 to 20 depending on the subscale. Higher scores indicate more of the construct being assessed.

5. Change in coping from baseline to immediately after the intervention [Baseline and immediately after the intervention]

   Participants will complete the Brief Coping Orientation to Problems Experienced scale, which yields 14 two-item subscales. Subscale scores range from 2 to 8, with higher scores indicating greater usage of the coping strategy being assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18-39 years at the time of participation

• diagnosed with a non-metastatic primary cancer between 18-39 years old

• completed primary cancer treatment (excepting hormone therapy) 1 month to 5 years prior to enrollment

• able to speak and read English

• access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

Exclusion Criteria:

• metastatic disease

• psychiatric or neurological disorders that could interfere with study participation

• considered part of a vulnerable population

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• American Cancer Society, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rina Fox, Research Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT05054569
• Other Study ID Numbers: NU 20CC18; IRG-18-163-24; STU00214055
• First Posted: Sep 23, 2021
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 4, 2022