EW and Self-Guided PST in Cancer Survivors and Caregivers

Expressive Writing (EW) and Self-Guided Problem-Solving Therapy (PST) in Cancer Survivors and Caregivers

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

Study Overview

• Status: Recruiting
• Conditions: Informal Caregivers; Cancer Survivors
• Intervention / Treatment: Behavioral: Expressive Writing and Problem-Solving Therapy (EW+PST)

Detailed Description

This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Massey CPC Team; Phone Number: 804-828-1965; Email: MasseyCPC@vcu.edu
• Study Contact Backup: Name: Kendra Rowe; Phone Number: 804-828-1965; Email: rowek2@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Principal Investigator: Susan Hong, MD
      • Contact: Massey CPC Team; Phone Number: 804-828-1965; Email: MasseyCPC@vcu.edu
      • Contact: Kendra Rowe; Phone Number: 804-828-1965; Email: rowek2@vcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expressive Writing and Problem-Solving Therapy; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks	The PTGI is a 21-item scale designed to assess individual growth following the experience of a traumatic experience, e.g. cancer. The items load onto 5 factors: personal strength, new possibilities, improved relationships, spiritual growth, and appreciation for life.Items are rated 0-5 and a total score is calculated by summing the responses to all items. Higher scores represent greater post-traumatic growth. There are also 5 factors which are scored by summing the items associated with each factor: Relating to Others; New Possibilities; Personal Strength; Spiritual Change; Appreciation of Life. Higher factor scores represent higher levels of each factor.	Baseline, Week 6
Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks	This measure consists of both multi-item and single-item scales. Raw scores are calculated for each scale, then transformed using linear transformation to standardize the raw score so that scores range from 0-100. Higher scores on functioning and quality of life scales represent better functioning/quality of life; higher scores on symptom scales represent worse functioning/quality of life.	Baseline, Week 6
Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks	The Patient Health Questionnaire-8 (PHQ-8) is an 8-item measure developed for use in clinical and research settings to assess symptoms of depression. Scores can be categorized into mild, moderate, and severe symptom severity. Items are rated 0-3 and a total score is calculated by summing the responses to all items. Higher scores represent greater symptoms of depression.	Baseline, Week 6
Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks	The PSS-10 is a 10-item scale used to assess self-reported stress. Items are scored 0-4 and a total score is calculated by summing the responses to all items. Higher scores represent greater perceived stress.	Baseline, Week 6
Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks	The New General Self-Efficacy Scale (GSES-N) is an 8-item measure that assesses how much people believe that they can achieve their goals despite encountering barriers, challenges, or difficulties. Items are scored 1-5 and a total score is calculated by averaging the responses to all items. Higher scores represent greater perceived self-efficacy.	Baseline, Week 6
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks	The MSPSS is a 12-item questionnaire of perceived social support from three sources: family, friends, and significant other. Items are scored 1-7 and a total score is calculated by averaging the responses to all items. There are also 3 subscales whose scores are calculated by averaging the responses to the associated items: Significant Other; Family; Friends. Higher scores represent greater perceived social support in total and for each subscale.	Baseline, Week 6
Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks	The FES-R is a 27-item true/false measure designed to characterize social and environmental characteristics of families: Cohesion, expressiveness, and conflict, The FES items are arranged so that each column of responses on the answer sheet constitutes one subscale. The number of responses given in the keyed direction as identified on the scoring key in each column, and enter the total in the raw score (RS) box at the bottom. (it's added, some are reverse coded). To determine the family's mean RS for each subscale, average the subscale raw scores for all members of that family. Relationship-Oriented Families. These families cannot be categorized as personal growth-oriented and have at least one elevated subscale within the relationship domain. Relationship-oriented families include: Ø Support-oriented families (15.3 percent; cohesion or expressiveness or both ≥ 60 and either cohesion or expressiveness ≥ conflict) Ø Conflict-oriented families (5.2 percent; conflict ≥ 60)	Baseline, Week 6
Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks	The CCAT-PF is an 18-item questionnaire that assesses congruence in patient-family caregiver communication; there are parallel versions of the instrument for patients and family members. Items are scored 1-6 and a total score is calculated by summing the responses to all items. Higher scores indicate greater perceived conflict.	Baseline, Week 6
Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks	The CBS is a 22-item self-report measure that assesses perceptions of burden related to providing care to someone with a chronic illness. The CBS has 5 factors: general strain, isolation, disappointment, emotional involvement, and environment. Items are scored 0-4 and a total score is calculated by summing the responses to all items. Higher scores indicate greater perceived burden.	Baseline, Week 6
Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks	The EORTC QLQ-30 is a 30-item self-report measure designed to assess health-related quality of life of cancer patients enrolled in clinical trials. It consists of both multi-item and single-item scales with higher scores reflecting higher scale value: for example, a high score on a symptom scale reflects higher symptom burden; a high score on a functional scale represents a higher level of functioning. The average raw score for each scale is transformed so that it falls within a range from 0 to 100.	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Susan Hong, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MCC-23-20794; HM20028614 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No