Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes

The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes/No) and if RTW happened then time to RTW.

In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Prostate Cancer; Radiation Injuries; Radiation Toxicity; Radiotherapy Side Effect; Malignancy; Cancer Survivors; Radiation Syndrome
• Intervention / Treatment: Radiation: Radiotherapy

Detailed Description

Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.

Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.

However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.

The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).

There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.

• Study Type: Observational
• Enrollment (Actual): 2135

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Jubileumskliniken, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort of women treated with external pelvic radiotherapy for a gynaecological malignancy and men treated with radiotherapy for prostate cancer at two large oncology clinics in Sweden.

Description

Inclusion Criteria:

1. Age 25 to 60 years (working age)
2. Employed at time of diagnosis
3. Treated for cancer
4. Suffering from at least one of Radiation-induced survivorship syndromes
5. First cancer & first time treatment for cancer,

Exclusion Criteria:

1. No other chronic disease
2. Chronic intestinal illness/surgery
3. Stage IV cancer
4. Recurrent cancer/Relapse

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gynecological Cases; Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at; Radiumhemmat, Karolinska University Hospital and; Jubileumskliniken at Sahlgrenska University Hospital in Sweden.	Radiation: Radiotherapy; Radiotherapy as part of cancer treatment
Prostate Cases; Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden	Radiation: Radiotherapy; Radiotherapy as part of cancer treatment
Gynecological Rehab Cases; Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy	Radiation: Radiotherapy; Radiotherapy as part of cancer treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work (RTW)	Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.	Five - Ten years after mapping Radiation-induced survivorship syndromes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Return to work	Sickness absence (more than 14 days) until the survivor returned to work. Also obtained from the official registries in Sweden.	Five - Ten years after mapping Radiation-induced survivorship syndromes

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Vastra Gotaland Region
• Investigators: Principal Investigator: Gunnar Steineck, Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden

Publications and helpful links

General Publications

• Steineck G, Skokic V, Sjoberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderang U, Oh JH, Deasy JO, Jornsten R. Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors. PLoS One. 2017 Feb 3;12(2):e0171461. doi: 10.1371/journal.pone.0171461. eCollection 2017.
• Dunberger G, Lind H, Steineck G, Waldenstrom AC, Nyberg T, Al-Abany M, Nyberg U, Vall-Lundqvist E. Self-reported symptoms of faecal incontinence among long-term gynaecological cancer survivors and population-based controls. Eur J Cancer. 2010 Feb;46(3):606-15. doi: 10.1016/j.ejca.2009.10.023. Epub 2009 Nov 18.
• Alsadius D, Hedelin M, Johansson KA, Pettersson N, Wilderang U, Lundstedt D, Steineck G. Tobacco smoking and long-lasting symptoms from the bowel and the anal-sphincter region after radiotherapy for prostate cancer. Radiother Oncol. 2011 Dec;101(3):495-501. doi: 10.1016/j.radonc.2011.06.010. Epub 2011 Jul 5.
• Lind H, Waldenstrom AC, Dunberger G, al-Abany M, Alevronta E, Johansson KA, Olsson C, Nyberg T, Wilderang U, Steineck G, Avall-Lundqvist E. Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort study. Br J Cancer. 2011 Sep 6;105(6):737-45. doi: 10.1038/bjc.2011.315. Epub 2011 Aug 16.
• Baloch AN, Hagberg M, Thomée S, Steineck G, Sandén H. Disability pension among gynaecological cancer survivors with or without radiation-induced survivorship syndromes. J Cancer Surviv. 2022 Aug;16(4):834-843. doi: 10.1007/s11764-021-01077-9. Epub 2021 Aug 19.

Helpful Links

• Self-reported symptoms of faecal incontinence among long-term gynaecological cancer survivors and population-based controls
• Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors
• Tobacco smoking and long-lasting symptoms from the bowel and the anal-sphincter region after radiotherapy for prostate cancer
• Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort study

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1991
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Wellbeing; Cancer Survivors; Return to work; Disability pension; Sickness Absence; Employability; Fitness to work; Radiotherapy Side Effect
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Syndrome; Radiation Injuries
• Other Study ID Numbers: ANB_691-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No