EW and Self-Guided PST in Cancer Survivors and Caregivers

NCT06282471 | Withdrawn

• 2 other identifiers: MCC-23-20794HM20028614
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers

Conditions

Cancer Survivors; Informal Caregivers

Outcome Measures

Primary Outcomes (4)

• Consent Rate

  Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.

  Day 1

• Study Retention

  Study retention will be analyzed as the number of participants completing the 6-week questionnaires

  Week 6

• Completed Journal Entries

  Number of completed journal entries will be tabulated from returned participant journals.

  Week 6

• Patient Satisfaction Questionnaire

  The number of participants that are satisfied with the intervention. Participants will be asked about their satisfaction with the program including perceived efficacy and suggestions for improvement

  Baseline, Week 6

Secondary Outcomes (10)

• Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks

  Baseline, Week 6

• Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks

  Baseline, Week 6

• Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks

  Baseline, Week 6

• Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks

  Baseline, Week 6

• Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks

  Baseline, Week 6

Study Arms (1)

Expressive Writing and Problem-Solving Therapy

EXPERIMENTAL

Self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

Behavioral: Expressive Writing and Problem-Solving Therapy (EW+PST)

Interventions

Expressive Writing and Problem-Solving Therapy (EW+PST) BEHAVIORAL

Participants will undergo a 6-week self-guided EW+PST. Participants will be provided with 6 printed journals (one for each week of the study) and instructed to write at least 2 entries per week.

Expressive Writing and Problem-Solving Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer diagnosis of any type OR informal caregiver (family member, friend, and/or spouse who provides the majority of caregiving) of someone with cancer
• Patient of Virginia Commonwealth University (VCU) Massey Cancer Center OR informal caregiver (family member, friend, and/or spouse) of a VCU Massey Cancer Center patient

You may not qualify if:

• Physical inability to write
• Non-English speaker/writer
• Inability to consent to study participation

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Officials

• Susan Hong, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: February 21, 2024
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share