Compassion-Based Rehabilitation Needs Assessment Following Colorectal Cancer Surgery

Keywords

• colonrectal cancer
• compassion
• randomized controlled trial
• Patient-centered care
• Cancer rehabilitation
• Needs assessment

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 50 studies on the registry; 15 are open to participants now.

Eligibility criteria

Study arms

• No intervention
  Standard Procedure

  Participants allocated to the control group received standard postoperative care following colorectal cancer surgery. Approximately two weeks after surgery, patients attended an outpatient follow-up consultation with a physician and a colorectal nurse. Subsequently, a nurse from the outpatient clinic conducted a telephone follow-up during which rehabilitation needs could be assessed using the standard needs assessment checklist. Patients with identified rehabilitation needs could be referred to municipal cancer rehabilitation services according to routine clinical procedures. No additional compassion-supported consultation was provided.

• Experimental
  Compassion intervention

  Participants allocated to the intervention group received standard postoperative care followed by an additional structured, compassion-supported rehabilitation needs assessment approximately seven days after the standard postoperative follow-up. The intervention consisted of an approximately 30-minute face-to-face consultation conducted by a registered nurse trained in compassion-based approaches. The consultation focused on identifying physical, psychological, and social rehabilitation needs through compassionate communication, attentive listening, and non-judgmental dialogue. Identified needs were discussed with the patient, and referral to municipal cancer rehabilitation services was facilitated through shared decision-making when appropriate.

  Behavioral: Compassionate Access Targeted Therapy

Interventions

• BehavioralCompassionate Access Targeted Therapy

  The intervention consisted of a structured, compassion-supported rehabilitation needs assessment delivered during an approximately 30-minute face-to-face consultation with a registered nurse trained in compassion-based approaches. The consultation took place approximately seven days after the standard postoperative follow-up visit. The intervention incorporated three components: (1) systematic identification of physical, psychological, and social rehabilitation needs using the standard needs assessment framework; (2) compassion-supported communication characterized by attentive listening, presence, openness, non-judgment, and sensitivity to patients' concerns; and (3) shared decision-making regarding referral to municipal cancer rehabilitation services. When rehabilitation needs were identified and the patient agreed, referral to municipal cancer rehabilitation was facilitated according to standard hospital procedures.

Primary outcomes

1. Health-Related Quality of Life Measured by FACT-C Total Score

   Health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire. The FACT-C measures physical, social, emotional, and functional well-being, as well as colorectal cancer-specific concerns. The total score ranges from 0 to 136, with higher scores indicating better health-related quality of life. The primary outcome is the between-group difference in FACT-C total score at the three-month follow-up.

   Time frame: 3 months after the intervention

Secondary outcomes

1. Anxiety Severity Measured by m-ESAS

   Anxiety will be assessed using the anxiety item from the Modified Edmonton Symptom Assessment System (m-ESAS). Scores range from 0 to 10, with higher scores indicating greater anxiety severity. Scores will be compared between the intervention and standard procedure groups.

   Time frame: Baseline, 1 month, and 3 months

2. Depression Severity Measured by m-ESAS

   Depression will be assessed using the depression item from the Modified Edmonton Symptom Assessment System (m-ESAS). Scores range from 0 to 10, with higher scores indicating greater depression severity. Scores will be compared between the intervention and standard procedure groups.

   Time frame: Baseline, 1 month, and 3 months

3. Self-Compassion Measured by the Self-Compassion Scale (SCS-26)

   Self-compassion will be assessed using the 26-item Self-Compassion Scale (SCS-26), comprising six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Items are rated on a five-point scale from 1 to 5. A total self-compassion score is calculated after reverse scoring negatively worded items, with higher scores indicating greater self-compassion.

   Time frame: Baseline, 1 month, and 3 months

4. Participation in Municipal Cancer Rehabilitation

   The proportion of participants who reported participation in municipal cancer rehabilitation services will be assessed at the three-month follow-up. Participation is defined as patient-reported engagement in a municipal cancer rehabilitation program during the follow-up period. The proportion of participants reporting rehabilitation participation will be compared between the two randomized groups.

   Time frame: Within 3 months after the intervention

Individual participant data

Plan to share: No — The datasets generated and analyzed during the current study are not publicly available due to privacy and data protection regulations. Data sharing is restricted by applicable Danish data protection legislation and institutional requirements.