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NCT Number: NCT04930016

Quality of Life and Survival of Patients With Colorectal Cancer 5 Years After Surgery - Follow-up of the RCT DIQOL

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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Key information

Conditions

Quality of Life Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg

Regensburg, Bavaria, 93053, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Quality of life diagnosis and therapy during the completed RCT DIQOL

Behavioral

Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. overall survival

    Time frame: surgery for colorectal cancer (01/2014-10/2015) up to 10/2021

    survival after surgery for colorectal cancer

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Tumor Center Regensburg

Other

Registry information

Official study 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

Acronym: DIQOLFollow-up

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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