EW and Self-Guided PST in Cancer Survivors and Caregivers

June 18, 2025 updated by: Virginia Commonwealth University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Consent Rate
Time Frame: Day 1
Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.
Day 1
Study Retention
Time Frame: Week 6
Study retention will be analyzed as the number of participants completing the 6-week questionnaires
Week 6
Completed Journal Entries
Time Frame: Week 6
Number of completed journal entries will be tabulated from returned participant journals.
Week 6
Patient Satisfaction Questionnaire
Time Frame: Baseline, Week 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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
Time Frame: Baseline, Week 6
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Hong, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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