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

• ClinicalTrials.gov Identifier: NCT03961217
• Recruitment Status: Completed
• First Posted: May 23, 2019
• Last Update Posted: May 28, 2019
• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborator: Vastra Gotaland Region
• Information provided by (Responsible Party): Gunnar Steineck, Sahlgrenska University Hospital, Sweden

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment
Gynecologic Cancer; Prostate Cancer; Radiation Toxicity; Malignancy; Radiotherapy Side Effect; Radiation Injuries; Cancer Survivors; Radiation Syndrome	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2135 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
• Actual Study Start Date: January 1991
• Actual Primary Completion Date: October 2006
• Actual Study Completion Date: December 2016

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Gyaecological cancer survivors Prostate cancer survivors
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

Sweden

Jubileumskliniken, Sahlgrenska University Hospital

Gothenburg, Sweden, 413 45

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Vastra Gotaland Region

Investigators

• Principal Investigator: Gunnar Steineck; Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden

More Information

Additional Information:

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 

Publications:

Steineck G, Skokic V, Sjöberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderäng U, Oh JH, Deasy JO, Jörnsten 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, Waldenström 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, Wilderäng 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, Waldenström AC, Dunberger G, al-Abany M, Alevronta E, Johansson KA, Olsson C, Nyberg T, Wilderäng U, Steineck G, Åvall-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.

• Responsible Party: Gunnar Steineck, Professor / Senior consultant, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT03961217
• Other Study ID Numbers: ANB_691-17
• First Posted: May 23, 2019
• Last Update Posted: May 28, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gunnar Steineck, Sahlgrenska University Hospital, Sweden:

Return to work; Disability pension; Sickness Absence; Employability; Fitness to work; Wellbeing; Radiotherapy Side Effect; Cancer Survivors

Additional relevant MeSH terms:

Syndrome; Radiation Injuries; Disease; Pathologic Processes; Wounds and Injuries