Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

The intervention group will receive face-to-face training, giving patient education booklet and telephone counseling based on the symptom management model. After the training, it is planned to provide telephone counseling for a total of 6 times, once every 2 weeks for 3 months.

CRCaSSM

Nazli Ozturk, MSC

Akdeniz University Hospital

Fatma Arikan

Objective: The aim of this study was to examine the effects of nursing interventions based on the symptom management model on symptom management, fear of recurrence, and quality of life in colorectal cancer survivors.

Method: The research was planned as a randomized controlled trial. The research is planned to be carried out at Akdeniz University Hospital. It is planned to be done with 52 patients, 26 experimental and 26 control groups. The intervention group will receive face-to-face training and telephone counseling based on the symptom management model. After the training, it is planned to provide telephone counseling for a total of 6 times, once every 2 weeks for 3 months. Participant Information Form, Memorial Symptom Assessment Scale, Fear of Cancer Recurrence Inventory and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale Scale will be used to collect data.

Colorectal Cancer Survivor Symptom Management

The Effect of Nursing Interventions Based on a Symptom Management Model on Symptom Management, Fear of Recurrence, and Quality of Life in Colorectal Cancer Survivors

Memorial Symptom Assessment Scale (MSAS): The Memorial Symptom Assessment Scale is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.

Fear of Cancer Recurrence Inventory (FCRI): It consists of 42 items with seven subscales triggers, severity, psychological distress, coping strategies, functioning impairments, insight, reassurance. FCRI, is a Likert-type scale that ranges from 0 (not at all/never) to 4 (all the time/a great deal). Increasing scores received from the scale demonstrate a high level of FCR. The minimum score to be taken from the scale is 0, and the maximum score is 168.

EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire): This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.

EORTC QLQ-CR29 The QLQ-CR29 includes 29 items that evaluate symptoms (gastrointestinal, urinary, pain and others) and functional areas (sexual, body image and others). Similar to the EORTC QLQ-C30, the QLQ-CR29 has a Likert scale of four response categories (item 48 requires a yes or no answer). All patient-rated scores are linearly converted into a scale from 0 to 100 for both the QLQ-C30 and QLQ-CR29.

Akdeniz University

Research Assistant

Cancer Pain

Pain

The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain as well as psychological distress.

The standard care control condition will receive resources and referrals related to survivorship health. This information will be provided to the participant during their initial survivorship care consult.

Telephone-Based Coping Skills Training (CST)

Sarah A. Kelleher, PhD

Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.

Pain Coping Skills for Colorectal Cancer Survivors

Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress

Client Satisfaction Questionnaire 10-item version.

The Functional Assessment of Cancer Therapy - General (FACT-G), version 4.0

Self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale

American Cancer Society, Inc.

Duke University

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the patient's ability, opportunities, and motivation will be increased, thereby promoting healthy behavior.

The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

multidimensional rehabilitation

Qu Shen

A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention

patients were randomly assigned to the rehabilitation group and control group by online randomization software

Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors

This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.

The FoP-Q-SF was developed by German scholar Herschbach in 2005 in people such as diabetes, rheumatic diseases and cancer, to measure patients' fear of disease progression or recurrence, a total of 7 dimensions, 43 entries, Cronbach's α is 0.7. It is a single-dimensional scale with a total of 12 items, using the Liket 5-level scoring method, the score range is 12\~60, the higher the score, the higher the level of fear.

Assessments of lifestyle behaviors will be conducted using a self-developed behavior scale, focusing on the frequency of behaviors such as diet and smoking.

The International Physical Activity Questionnaire (IPAQ) is a commonly used tool for assessing individuals' levels of physical activity in their daily lives. It aims to measure individuals' physical activity over the past 7 days, including overall physical activity levels and the frequency of activities.

Ability to test mobility and posture transposition. Using a chair without armrests, the number of times the participant could change from a sitting state (leaning back on the chair with both feet on the ground) to fully standing within 30 s was counted. Two tests were performed, with 1 min of rest in between, and the average value was rounded to the nearest value.

BMI reflects the patient's nutritional status and physical fitness.

The First Affiliated Hospital of Xiamen University

Associate Professor

A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention.

Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study

Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors - a Pilot Study

Record the occurrence of adverse events, including nausea, vomiting, pain, etc.

The number of days per week that participants complied with the protocol will be recorded over a 4-week period.

Record the number and reasons for loss to follow-up

After the intervention, semi-structured interviews were conducted with the participants. The main topics covered included the benefits and adverse reactions of the multidimensional rehabilitation intervention, factors that facilitated or hindered participation in the multidimensional rehabilitation, and the pros and cons of the metaverse platform.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Pain Coping Skills for Colorectal Cancer Survivors	NCT02706301	Colorectal Canc...	Telephone-Based...	21 Years - 80 Years	Duke University
Pain Coping Skills for Colorectal Cancer Survivors	NCT02706301	Colorectal Canc...	Telephone-Based...	21 Years - 80 Years	Duke University
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors	NCT05956990	Colorectal Canc... Rehabilitation Quality of Life	multidimensiona...	18 Years - 65 Years	Xiamen University
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study	NCT05957289	Rehabilitation Colorectal Canc... Quality of Life Pilot Study	multidimensiona...	18 Years - 65 Years	Xiamen University
Pain Coping Skills for Colorectal Cancer Survivors	NCT02706301	Colorectal Canc...	Telephone-Based...	21 Years - 80 Years	Duke University
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study	NCT05957289	Rehabilitation Colorectal Canc... Quality of Life Pilot Study	multidimensiona...	18 Years - 65 Years	Xiamen University
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University

Spots Global Cancer Trial Database for colorectal cancer survivor