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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961217
• Other study ID #: ANB_691-17
• Status: Completed
• Start date: January 1991
• Est. completion date: December 2016

Study information

• Verified date: May 2019
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2135
• Est. completion date: December 2016
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivors
• Gynecologic Cancer
• Malignancy
• Prostate Cancer
• Radiation Injuries
• Radiation Syndrome
• Radiation Toxicity
• Radiotherapy Side Effect
• Syndrome

Intervention

Radiation:
• Radiotherapy
Radiotherapy as part of cancer treatment

Locations

Country	Name	City	State
Sweden	Jubileumskliniken, Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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