Clinical trial NCT03961217: Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
Official title: Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Prostate Cancer
Radiation Toxicity
Malignancy
Radiotherapy Side Effect
Radiation Injuries
Cancer Survivors
Radiation Syndrome
Keywords: Return to work
Disability pension
Sickness Absence
Employability
Fitness to work
Wellbeing
Radiotherapy Side Effect
Cancer Survivors
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2019-05-23
Enrollment: 2135
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Return to work (RTW)
timeFrame: Five - Ten years after mapping Radiation-induced survivorship syndromes
Secondary outcomes:
measure: Time to Return to work
timeFrame: Five - Ten years after mapping Radiation-induced survivorship syndromes
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Jubileumskliniken, Sahlgrenska University Hospital
Study officials:
affiliation: Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden
name: Gunnar Steineck
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Baloch AN, Hagberg M, Thomee S, Steineck G, Sanden 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.