Colonrectal CancerNCT07876388
Compassion-Based Rehabilitation Needs Assessment Following Colorectal Cancer Surgery
A study testing Compassionate Access Targeted Therapy in people with Colonrectal Cancer and Colonrectal Cancer (CRC), run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
This randomized controlled trial evaluated the effect of a compassion-based intervention compared with standard procedure for rehabilitation needs assessment among patients undergoing surgery for colorectal cancer with curative intent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonrectal Cancer, Colonrectal Cancer (CRC)
- What is being tested?
- Compassionate Access Targeted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2023to 4 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients undergoing surgery with curative intent for colorectal cancer (colon or rectal cancer).
- Able to speak and understand Danish.
Who cannot join
- Patients younger than 18 years.
- Patients unable to speak or understand Danish.
- Patients not undergoing surgery with curative intent for colorectal cancer.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassion Intervention Versus Standard Procedure in Rehabilitation Needs Assessment Following Colorectal Cancer Surgery: A Randomized Controlled Trial
This randomized controlled trial evaluated the effect of a compassion-based intervention compared with standard procedure for rehabilitation needs assessment among patients undergoing surgery for colorectal cancer with curative intent.
Participants were randomly assigned to either a structured, compassion-supported rehabilitation needs assessment or standard postoperative care. The intervention focused on identifying physical, psychological, and social rehabilitation needs through compassionate communication and facilitating referral to municipal cancer rehabilitation services.
The primary outcome was health-related quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) at three months. Secondary outcomes included anxiety, depression, self-compassion, and participation in cancer rehabilitation.
- Conditions
- Colonrectal Cancer, Colonrectal Cancer (CRC)
- Being tested
- Compassionate Access Targeted Therapy
- Keywords
- colonrectal cancer, compassion, randomized controlled trial, Patient-centered care, Cancer rehabilitation, Needs assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassionate Access Targeted TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Procedure | No intervention | 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. |
| Compassion intervention | Experimental | 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. Receives: Behavioral: Compassionate Access Targeted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the intervention
Secondary outcomes (4)
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.
Measured: Baseline, 1 month, and 3 months
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.
Measured: Baseline, 1 month, and 3 months
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.
Measured: Baseline, 1 month, and 3 months
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.
Measured: Within 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start10 Oct 2023
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonrectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876388
- Sponsor's protocol ID
- 23/25778
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion Intervention Versus Standard Procedure in Rehabilitation Needs Assessment Following Colorectal Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07876388
- Acronym / sponsor ID
- 23/25778
- Conditions
- Colonrectal Cancer, Colonrectal Cancer (CRC)
- Keywords
- colonrectal cancer, compassion, randomized controlled trial, Patient-centered care, Cancer rehabilitation, Needs assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated the effect of a compassion-based intervention compared with standard procedure for rehabilitation needs assessment among patients undergoing surgery for colorectal cancer with curative intent.
Participants were randomly assigned to either a structured, compassion-supported rehabilitation needs assessment or standard postoperative care. The intervention focused on identifying physical, psychological, and social rehabilitation needs through compassionate communication and facilitating referral to municipal cancer rehabilitation services.
The primary outcome was health-related quality of life measured using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) at three months. Secondary outcomes included anxiety, depression, self-compassion, and participation in cancer rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Procedure | No intervention | –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. |
| Compassion intervention | Experimental | Behavioral: Compassionate Access Targeted TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Patients undergoing surgery with curative intent for colorectal cancer (colon or rectal cancer).
- Able to speak and understand Danish.
Key exclusion criteria (4 listed)
- Patients younger than 18 years.
- Patients unable to speak or understand Danish.
- Patients not undergoing surgery with curative intent for colorectal cancer.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassionate Access Targeted TherapyThe 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. | Behavioural | Compassion intervention |
Primary outcome
Health-Related Quality of Life Measured by FACT-C Total Score
Time frame: 3 months after the intervention
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.
4 secondary outcomes
Anxiety Severity Measured by m-ESAS
Time frame: Baseline, 1 month, and 3 months
Depression Severity Measured by m-ESAS
Time frame: Baseline, 1 month, and 3 months
Self-Compassion Measured by the Self-Compassion Scale (SCS-26)
Time frame: Baseline, 1 month, and 3 months
Participation in Municipal Cancer Rehabilitation
Time frame: Within 3 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Colonrectal Cancer
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Not yet recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassionate Access Targeted Therapy in people with Colonrectal Cancer and Colonrectal Cancer (CRC), run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life Measured by FACT-C Total Score (time frame: 3 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.