Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06282471
Other study ID # MCC-23-20794
Secondary ID HM20028614
Status Recruiting
Phase N/A
First received
Last updated
Start date February 21, 2024
Est. completion date March 31, 2026

Study information

Verified date February 2024
Source Virginia Commonwealth University
Contact Kendra Rowe
Phone 804-828-1965
Email rowek2@vcu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Consent Rate Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals. Day 1
Primary Study Retention Study retention will be analyzed as the number of participants completing the 6-week questionnaires Week 6
Primary Completed Journal Entries Number of completed journal entries will be tabulated from returned participant journals. Week 6
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06028048 - Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors Phase 2/Phase 3
Recruiting NCT04439461 - Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors
Completed NCT04498130 - Feasibility of a Novel, Theory Based Physical Activity Intervention Among Adult Cancer Survivors N/A
Completed NCT05473026 - Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors N/A
Completed NCT05582889 - Move For Your Health for Older Cancer Survivors N/A
Completed NCT04339959 - Remote Assessment of Physical Function
Recruiting NCT05193149 - Inspiratory Muscle Training in Obese Breast Cancer Survivors N/A
Recruiting NCT03750981 - C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study) N/A
Completed NCT04751305 - Remote Exercise Maintenance With Health Coaching for Cancer Survivors N/A
Completed NCT02152020 - Patient-Centered Acupuncture for Pain (PCAP) N/A
Recruiting NCT05865678 - Musculoskeletal Health in Adult Haematological Cancer Survivors
Recruiting NCT06234267 - Eat, Play, Sleep: A Text Message Approach to Promoting Health Behaviors for Cancer Survivors and Their Caregivers N/A
Recruiting NCT05194397 - Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors Phase 2
Completed NCT01108484 - Program of Exercise, Diet and Control of Psychological Stress in Cancer Survivors N/A
Recruiting NCT06205251 - Diaphragm Structure and Function in Childhood Cancer Survivors N/A
Completed NCT03459781 - Compassion Meditation for Cancer Survivor-Caregiver Dyads Phase 1/Phase 2
Active, not recruiting NCT06046573 - Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors N/A
Recruiting NCT05519982 - Sleep Treatment Education Program-1 (STEP-1) N/A
Completed NCT03981809 - Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan
Active, not recruiting NCT04245943 - Rehabilitation - Physical Activity and Coping N/A