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

NCT ID: NCT03961217

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2135 participants

Study Classification

OBSERVATIONAL

Study Start Date

1991-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Gynecological Cases

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at

1. Radiumhemmat, Karolinska University Hospital and
2. Jubileumskliniken at Sahlgrenska University Hospital in Sweden.

Radiotherapy

Intervention Type RADIATION

Radiotherapy as part of cancer treatment

Prostate Cases

Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden

Radiotherapy

Intervention Type RADIATION

Radiotherapy as part of cancer treatment

Gynecological Rehab Cases

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy

Radiotherapy

Intervention Type RADIATION

Radiotherapy as part of cancer treatment

Interventions

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Radiotherapy

Radiotherapy as part of cancer treatment

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Steineck

Professor / Senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Steineck

Role: PRINCIPAL_INVESTIGATOR

Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden

Locations

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Jubileumskliniken, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 28158314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19926277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21737169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21847122 (View on PubMed)

Noor Baloch A, Hagberg M, Thomee S, Steineck G, Sanden H. The physical and psychological aspects of quality of life mediates the effect of radiation-induced urgency syndrome on disability pension in gynecological cancer survivors. Cancer Med. 2023 Aug;12(16):17377-17388. doi: 10.1002/cam4.6356. Epub 2023 Jul 24.

Reference Type DERIVED
PMID: 37489096 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34414517 (View on PubMed)

Related Links

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https://doi.org/10.1016/j.ejca.2009.10.023

Self-reported symptoms of faecal incontinence among long-term gynaecological cancer survivors and population-based controls

https://dx.doi.org/10.1371%2Fjournal.pone.0171461

Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors

https://doi.org/10.1016/j.radonc.2011.06.010

Tobacco smoking and long-lasting symptoms from the bowel and the anal-sphincter region after radiotherapy for prostate cancer

https://www.nature.com/articles/bjc2011315

Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort study

Other Identifiers

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ANB_691-17

Identifier Type: -

Identifier Source: org_study_id

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