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Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL (DIQOLFollow-up)
This observational follow-up study of the randomized trial (RCT) DIQOL investigates long-term effects of an intervention with quality of life (QoL) diagnosis and therapy on present QoL, survival, and recurrence-free survival of colorectal cancer survivors more than 5 years after surgery.
Moreover, patients' experiences with aftercare for colorectal cancer during the COVID-19 pandemic and their recollections of their illness and therapy are examined.
| Condition or disease | Intervention/treatment |
|---|---|
| Quality of Life Colorectal Cancer Colorectal Neoplasms Survivorship | Behavioral: Quality of life diagnosis and therapy during the completed RCT DIQOL |
In a complex intervention a clinical pathway with quality of life (QoL) diagnosis and tailored therapy had been developed for patients with colorectal cancer and its effectiveness was evaluated in a randomized trial (RCT DIQOL, NCT02321813, Klinkhammer-Schalke et al, 2020). In the RCT DIQOL a total of 220 patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's doctor (intervention) or standard postoperative care (control). QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery and during aftercare (3, 6, 12, 18 months postoperatively). A need for QoL therapy was defined as a score <50 points on at least one QoL scale. It was demonstrated that the proportion of patients with a need for QoL therapy was significantly lower in intervention group patients at 12 months after surgery (primary endpoint).
Until now, it is unclear whether there are also long-term benefits of QoL diagnosis and therapy. Therefore, the aim of this observational, cross-sectional follow-up study of the RCT DIQOL is to investigate long-term effects of the intervention on present QoL (EORTC QLQ-C30, QLQ-CR29), overall survival, and recurrence-free survival more than 5 years after surgery by comparing former intervention and control group patients. Moreover, participants will be asked for their experiences during aftercare in relation of the COVID-19 pandemic and for their recollection of their illness and therapy. Data are collected via questionnaire.
| Study Type : | Observational |
| Actual Enrollment : | 208 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery and Their Aftercare Situation During the COVID-19 Pandemic - Long-term Follow-up of the Randomized Trial DIQOL |
| Actual Study Start Date : | April 14, 2021 |
| Actual Primary Completion Date : | October 7, 2021 |
| Actual Study Completion Date : | October 7, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Former DIQOL intervention group
In the present follow-up study no interventions are administered. This group encompasses patients who had been part of the intervention group of the completed RCT DIQOL with the following intervention: Patients answered QoL questionnaires after surgery and at 3, 6, 12, and 18 months postoperatively. Results were transferred to a QoL-profile consisting of 13 QoL scales. Three experts with various professional background used the individual patient's QoL-profile and clinical and sociodemographic information to generate a QoL-report including therapy recommendations which was sent to the patient's doctor. Specific therapeutic options for the treatment of QoL had been defined: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, and fitness.
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Behavioral: Quality of life diagnosis and therapy during the completed RCT DIQOL
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
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Former DIQOL control group
In the present follow-up study no interventions are administered. This group encompasses patients who had been part of the control group of the completed RCT DIQOL: Patients answered QoL questionnaires after surgery and at 3, 6, 12, and 18 months postoperatively but their doctor neither received a QoL-profile nor a QoL-report.
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- need for QoL therapy of colorectal cancer survivors [ Time Frame: >5 years after surgery for colorectal cancer ]proportion of patients in both groups with a need for QoL therapy (<50 points in at least one dimension) more than 5 years after surgery
- specific need for QoL therapy of colorectal cancers survivors in specific QoL dimensions [ Time Frame: >5 years after surgery for colorectal cancer ]rates of patients with a need for QoL therapy in each single dimension of the QoL-profile more than 5 years after surgery
- overall survival [ Time Frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021 ]survival after surgery for colorectal cancer
- recurrence-free survival [ Time Frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021 ]recurrence-free survival after surgery for colorectal cancer
- aftercare of colorectal cancer survivors during the COVID-19 pandemic [ Time Frame: >5 years after surgery for colorectal cancer ]self-created questionnaire with quantitative questions asking whether and how the COVID-19 pandemic affected ´aftercare
- colorectal cancer survivors' recollections of their illness an therapy [ Time Frame: >5 years after surgery for colorectal cancer ]self-created questionnaire with three qualitative questions asking for worst experiences during the colorectal cancer episode, positive aspects of the illness, and any advice survivors would give to newly diagnosed patients
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- former participants of the RCT DIQOL with a primary diagnosis of colorectal cancer between 01/2014 and 10/2015 who did not refuse to participate during the RCT
- informed consent
Exclusion Criteria:
- none -
| Germany | |
| Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg | |
| Regensburg, Bavaria, Germany, 93053 | |
| Study Chair: | Monika Klinkhammer-Schalke, MD, Prof. | Tumor Center Regensburg | |
| Principal Investigator: | Patricia Lindberg-Scharf, PhD | Tumor Center Regensburg |
| Tracking Information | |||||||||
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| First Submitted Date | June 10, 2021 | ||||||||
| First Posted Date | June 18, 2021 | ||||||||
| Last Update Posted Date | November 29, 2021 | ||||||||
| Actual Study Start Date | April 14, 2021 | ||||||||
| Actual Primary Completion Date | October 7, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL | ||||||||
| Official Title | Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery and Their Aftercare Situation During the COVID-19 Pandemic - Long-term Follow-up of the Randomized Trial DIQOL | ||||||||
| Brief Summary |
This observational follow-up study of the randomized trial (RCT) DIQOL investigates long-term effects of an intervention with quality of life (QoL) diagnosis and therapy on present QoL, survival, and recurrence-free survival of colorectal cancer survivors more than 5 years after surgery. Moreover, patients' experiences with aftercare for colorectal cancer during the COVID-19 pandemic and their recollections of their illness and therapy are examined. |
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| Detailed Description |
In a complex intervention a clinical pathway with quality of life (QoL) diagnosis and tailored therapy had been developed for patients with colorectal cancer and its effectiveness was evaluated in a randomized trial (RCT DIQOL, NCT02321813, Klinkhammer-Schalke et al, 2020). In the RCT DIQOL a total of 220 patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's doctor (intervention) or standard postoperative care (control). QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery and during aftercare (3, 6, 12, 18 months postoperatively). A need for QoL therapy was defined as a score <50 points on at least one QoL scale. It was demonstrated that the proportion of patients with a need for QoL therapy was significantly lower in intervention group patients at 12 months after surgery (primary endpoint). Until now, it is unclear whether there are also long-term benefits of QoL diagnosis and therapy. Therefore, the aim of this observational, cross-sectional follow-up study of the RCT DIQOL is to investigate long-term effects of the intervention on present QoL (EORTC QLQ-C30, QLQ-CR29), overall survival, and recurrence-free survival more than 5 years after surgery by comparing former intervention and control group patients. Moreover, participants will be asked for their experiences during aftercare in relation of the COVID-19 pandemic and for their recollection of their illness and therapy. Data are collected via questionnaire. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Former participants of the RCT DIQOL with a primary diagnosis of colorectal cancer between 01/2014 and 10/2015 who had been surgically treated in one of four participating certified centers for colorectal cancer (Krankenhaus Barmherzige Brüder Regensburg, Germany; Caritas-Krankenhaus St. Josef Regensburg, Germany; Klinikum Neumarkt, Germany; Klinikum St. Elisabeth Straubing, Germany). Originally, 220 patients were included in the RCT DIQOL. Of the 220 participants who were included in the RCT 12 patients refused participation during the trial so that the final sample for the follow-up study encompasses 208 patients. The questionnaire is mailed to survivors of this cohort. Overall survival and recurrence-free surival will be analzyed in all 208 former study participants. | ||||||||
| Condition |
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| Intervention | Behavioral: Quality of life diagnosis and therapy during the completed RCT DIQOL
Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
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| Study Groups/Cohorts |
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| Publications * | Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Fürst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Completed | ||||||||
| Actual Enrollment |
208 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Actual Study Completion Date | October 7, 2021 | ||||||||
| Actual Primary Completion Date | October 7, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: - none - |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04930016 | ||||||||
| Other Study ID Numbers | DIQOL_Follow-up_2021 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Prof. Dr. Monika Klinkhammer-Schalke, Tumor Center Regensburg | ||||||||
| Study Sponsor | Tumor Center Regensburg | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Tumor Center Regensburg | ||||||||
| Verification Date | November 2021 | ||||||||